On October 20, the Second National Experience Exchange Meeting of GMP for Medical Devices, sponsored by China Association for Medical Devices Industry, was convened under the guidance of the Medical Device Supervision and Management Department of National Medical Products Administration. This meeting, as one of the key activities of the "National Medical Device Safety Publicity Week" in 2020, aims to promote the overall improvement of the quality management system for the production of medical devices in the whole industry, boost the high-quality development of the industry, and effectively protect the safety of public medical devices through the exchange of advanced experience of the companies and the demonstration role of typical companies.
The responsible persons of relevant departments and divisions as well as directly affiliated institutions of National Medical Products Administration, relevant personnel of China Association for Medical Devices Industry, representatives of 10 medical device manufacturers, relevant personnel of medical device supervision of Beijing Medical Products Bureau, Tianjin Medical Products Bureau and Hebei Provincial Medical Products Bureau and representatives of local companies attended the meeting at the main venue. Medical device supervision personnel from other provinces (municipalities and cities) and representatives of local companies attended the meeting at each sub-venue by means of live video streaming. The 100 manufacturers with advanced experience in the production quality management of medical devices recommended by all provinces this year and the 100 manufacturers attending the First National Experience Exchange Meeting of GMP for Medical Devices in 2019 attended the meeting.
At the meeting, Zhao Yixin, President of China Association for Medical Devices Industry, delivered a speech. President Zhao said that this meeting builds a platform for exchange and cooperation among regulatory authorities, manufacturers, medical institutions and research institutes. He hoped that through this meeting, manufacturers could improve their understanding of risk management of medical devices and go a step further in the GMP for medical devices. In addition, Zhao suggested that the regulatory authorities should further raise the threshold for risk management of medical devices before and after marketing, promote the risk management of manufacturing companies, improve and develop the risk management theory of medical devices according to the actual situation of China, formulate policies and regulations more in line with China's national conditions, and promote the high quality development of the medical equipment industry in China.
The representatives of 10 medical device manufacturers including Shandong Kangli Medical Equipment Technology Co., Ltd., Winner Medical (Huanggang) Co., Ltd., Shanghai Yuanxin MedTech Co., Ltd., BGI Biotechnology Wuhan Co., Ltd., Beijing Ak Medical Co., Ltd., Jiangsu Rehn Medtech Co., Ltd., Shanghai Ezisurg Medical Co., Ltd., Chengdu OCI Medical Devices Co., Ltd., Zhejiang Guangci Medical Devices Co., Ltd., Shenzhen SonoScape Co., Ltd. exchanged views on how management representatives perform their duties, how to strengthen quality control, how to promote the standardized operation of the quality management system, how to monitor the adverse event and other topics, and shared their experience in standardizing implementation and establishing a sound system. Shi Lei, Deputy Director of the Food and Drug Inspection Center of the National Medical Products Administration introduced the unannounced inspections of the medical device manufacturers.
The companies attending the meeting expressed that they should have a thorough understanding of the importance of the medical device production management system, further strengthen the construction of the medical device production quality management system and the construction of the system management talent team, constantly promote the standardized and effective operation of the quality management system, implement the main responsibility of companies, and continue to facilitate the modernization of the company management system and management capacity.
At last, Wang Shucai, Deputy Director of the Department of Medical Device Supervision of the National Medical Products Administration, summarized the meeting. Director Wang said that after years of development, the gradual development of the quality management system of medical device manufacturers has made great progress. The concept of the system has been continuously deepened, the implementation level has been continuously consolidated, the norms and standards have been continuously improved, and the international exchanges and cooperation have been continuously strengthened. In particular, the quality of medical equipment for COVID-19 prevention and control has been effectively guaranteed during the battle against COVID-19, which shows that the achievements of the GMP for medical devices have withstood the test. It is required to comprehensively establish the concept of the quality management system, benchmark international advanced practical experience, explore ways to establish standards and management systems that are suitable for the actual conditions of companies and meet the requirements of laws and regulations. Additionally, it is required to comprehensively improve the overall quality management level of the company, continue to fill in the blanks, strengthen the advanced systems, implement the requirements of internal audit and management review of the quality management system, innovate mechanisms and enrich methods to enhance the overall regulatory awareness of medical device industry personnel, build a strong social co-governance system of medical device quality safety, and facilitate the improvement of the overall quality and safety level of China's medical devices.
The responsible persons of relevant departments and divisions as well as directly affiliated institutions of National Medical Products Administration, relevant personnel of China Association for Medical Devices Industry, representatives of 10 medical device manufacturers, relevant personnel of medical device supervision of Beijing Medical Products Bureau, Tianjin Medical Products Bureau and Hebei Provincial Medical Products Bureau and representatives of local companies attended the meeting at the main venue. Medical device supervision personnel from other provinces (municipalities and cities) and representatives of local companies attended the meeting at each sub-venue by means of live video streaming. The 100 manufacturers with advanced experience in the production quality management of medical devices recommended by all provinces this year and the 100 manufacturers attending the First National Experience Exchange Meeting of GMP for Medical Devices in 2019 attended the meeting.
At the meeting, Zhao Yixin, President of China Association for Medical Devices Industry, delivered a speech. President Zhao said that this meeting builds a platform for exchange and cooperation among regulatory authorities, manufacturers, medical institutions and research institutes. He hoped that through this meeting, manufacturers could improve their understanding of risk management of medical devices and go a step further in the GMP for medical devices. In addition, Zhao suggested that the regulatory authorities should further raise the threshold for risk management of medical devices before and after marketing, promote the risk management of manufacturing companies, improve and develop the risk management theory of medical devices according to the actual situation of China, formulate policies and regulations more in line with China's national conditions, and promote the high quality development of the medical equipment industry in China.
The representatives of 10 medical device manufacturers including Shandong Kangli Medical Equipment Technology Co., Ltd., Winner Medical (Huanggang) Co., Ltd., Shanghai Yuanxin MedTech Co., Ltd., BGI Biotechnology Wuhan Co., Ltd., Beijing Ak Medical Co., Ltd., Jiangsu Rehn Medtech Co., Ltd., Shanghai Ezisurg Medical Co., Ltd., Chengdu OCI Medical Devices Co., Ltd., Zhejiang Guangci Medical Devices Co., Ltd., Shenzhen SonoScape Co., Ltd. exchanged views on how management representatives perform their duties, how to strengthen quality control, how to promote the standardized operation of the quality management system, how to monitor the adverse event and other topics, and shared their experience in standardizing implementation and establishing a sound system. Shi Lei, Deputy Director of the Food and Drug Inspection Center of the National Medical Products Administration introduced the unannounced inspections of the medical device manufacturers.
The companies attending the meeting expressed that they should have a thorough understanding of the importance of the medical device production management system, further strengthen the construction of the medical device production quality management system and the construction of the system management talent team, constantly promote the standardized and effective operation of the quality management system, implement the main responsibility of companies, and continue to facilitate the modernization of the company management system and management capacity.
At last, Wang Shucai, Deputy Director of the Department of Medical Device Supervision of the National Medical Products Administration, summarized the meeting. Director Wang said that after years of development, the gradual development of the quality management system of medical device manufacturers has made great progress. The concept of the system has been continuously deepened, the implementation level has been continuously consolidated, the norms and standards have been continuously improved, and the international exchanges and cooperation have been continuously strengthened. In particular, the quality of medical equipment for COVID-19 prevention and control has been effectively guaranteed during the battle against COVID-19, which shows that the achievements of the GMP for medical devices have withstood the test. It is required to comprehensively establish the concept of the quality management system, benchmark international advanced practical experience, explore ways to establish standards and management systems that are suitable for the actual conditions of companies and meet the requirements of laws and regulations. Additionally, it is required to comprehensively improve the overall quality management level of the company, continue to fill in the blanks, strengthen the advanced systems, implement the requirements of internal audit and management review of the quality management system, innovate mechanisms and enrich methods to enhance the overall regulatory awareness of medical device industry personnel, build a strong social co-governance system of medical device quality safety, and facilitate the improvement of the overall quality and safety level of China's medical devices.